Who is sponsoring NCT04803734?

NCT04803734 is sponsored by Intech Biopharm Ltd..

What drugs are being tested in NCT04803734?

Interventions in NCT04803734: Albuterol Sulfate inhalation aerosol 108mcg per actuation, Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation.

Is NCT04803734 still recruiting?

NCT04803734 is currently completed. Last updated 18 March 2024.

Are results published for NCT04803734?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-03-18 · How we verify

NCT04803734

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Bioequivalence Between Albuterol Sulfate Inhalation Aerosol 108 mcg Per Actuation and Proair HFA (Albuterol Sulfate) Inhalation Aerosol 90 mcg Per Actuation in Healthy Volunteers Under Fasting Conditions

Completed NA Results posted Last updated 18 March 2024

What this trial tests

NA trial testing Albuterol Sulfate inhalation aerosol 108mcg per actuation in Healthy in 60 participants. Completed in 14 May 2021.

Timeline

19 March 2021

Primary endpoint
10 May 2021

14 May 2021

Quick facts

Lead sponsor	Intech Biopharm Ltd.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	60
Start date	19 March 2021
Primary completion	10 May 2021
Estimated completion	14 May 2021
Sites	1 location across Taiwan

Drugs / interventions tested

Albuterol Sulfate inhalation aerosol 108mcg per actuation — full drug profile →
Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Intech Biopharm Ltd. — full company profile →

Who can join

Adults 20 to 60, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Cmax Primary · 0 hour (pre-dose), as well as at 2, 5, 10, 15, 20, 30, 45 minutes, and 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours post-dose

The maximal observed plasma concentration of Albuterol Sulfate.

Group	Value	95% CI
Albuterol Sulfate Inhalation Aerosol	812.477	± 281.148
Proair HFA (Albuterol Sulfate) Inhalation Aerosol	945.456	± 359.695

AUC(0-t) Primary · 0 hour (pre-dose), as well as at 2, 5, 10, 15, 20, 30, 45 minutes, and 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours post-dose

Area under the concentration time curve from time zero until the last measurable concentration or last sampling time t, whichever occurs first.

Group	Value	95% CI
Albuterol Sulfate Inhalation Aerosol	4806.319	± 981.477
Proair HFA (Albuterol Sulfate) Inhalation Aerosol	5090.449	± 1053.602

AUC(0-inf) Primary · 0 hour (pre-dose), as well as at 2, 5, 10, 15, 20, 30, 45 minutes, and 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours post-dose

Area under the concentration time curve from time zero to infinity.

Group	Value	95% CI
Albuterol Sulfate Inhalation Aerosol	5204.806	± 1081.862
Proair HFA (Albuterol Sulfate) Inhalation Aerosol	5509.006	± 1148.747

Tmax Secondary · 0-24 hours

Time when the maximal plasma concentration is observed.

Group	Value	95% CI
Albuterol Sulfate Inhalation Aerosol	0.929	± 1.089
Proair HFA (Albuterol Sulfate) Inhalation Aerosol	0.514	± 0.529

T1/2 Secondary · 0-24 hours

Terminal elimination half-life, estimated as ln(2)/λ.

Group	Value	95% CI
Albuterol Sulfate Inhalation Aerosol	6.928	± 1.165
Proair HFA (Albuterol Sulfate) Inhalation Aerosol	6.985	± 1.357

Kel(λ) Secondary · 0-24 hours

Terminal elimination rate constant, estimated by linear regression analysis of the terminal portion of the ln-concentration vs. time plot.

Group	Value	95% CI
Albuterol Sulfate Inhalation Aerosol	0.103	± 0.019
Proair HFA (Albuterol Sulfate) Inhalation Aerosol	0.103	± 0.021

Mean Residence Time (MRT) Secondary · 0-24 hours

Mean residence time (MRT) is calculated by the area under the first moment curve dividing by area under the concentration time curve.

Group	Value	95% CI
Albuterol Sulfate Inhalation Aerosol	8.629	± 1.202
Proair HFA (Albuterol Sulfate) Inhalation Aerosol	8.474	± 1.455

Adverse events — posted to ClinicalTrials.gov

Time frame: Approximately 16 days for each subject.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Test Group

Serious: 0/60 (0%)

Deaths: 0/60

Reference Group

Serious: 0/58 (0%)

Deaths: 0/58

Other adverse events (5 terms — click to expand)

Reaction	System	Test Group	Reference Group
Throat infection	Infections and infestations	—	—
Aspartate aminotransferase (AST) increased	Investigations	—	—
Creatinine increased	Investigations	—	—
Alanine aminotransferase (ALT) increased	Investigations	—	—
Hypertriglyceridemia	Metabolism and nutrition disorders	—	—

Data from ClinicalTrials.gov NCT04803734 adverse events section.

Sponsor's own description

This study was designed to assess the bioequivalence between the test products (Albuterol Sulfate Inhalation Aerosol 108 mcg Per Actuation) and the reference products (Proair HFA \[Albuterol Sulfate\] Inhalation Aerosol 90 mcg Per Actuation) in healthy volunteers under fasting conditions. The test product was considered bioequivalent to the reference product if the T/R ln-transformed AUC(0-t), AUC(0-inf), and Cmax were within 80.00-125.00% of those of the reference.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other Intech Biopharm Ltd. trials

Trials by the same sponsor.

NCT05300087 — Bioequivalence Between Albuterol Sulfate Inhalation Aerosol 108mcg Per Actuation and Proair HFA (Albuterol Sulfate) Inha · NA · completed
NCT05152355 — Clinical Equivalence of Budesonide HFA MDI Versus Budesonide Turbuhaler in Mild to Moderate Chinese Asthma Patients · Phase 4 · completed
NCT04494321 — A Bioequivalence Pivotal Study of SYN010 HFA Inhaler and Symbicort® 160/4.5 in Healthy Volunteers Without Charcoal Block · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04803734 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Intech Biopharm Ltd.
Last refreshed: 18 March 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04803734.

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